A trial of AMG 337 for advanced solid tumours that have a large number of copies of a gene called MET

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

All cancer types

Status:

Closed

Phase:

Phase 2

This trial is looking at a drug called AMG 337 for advanced cancer. It is for people who have a solid tumour that has a lot of copies of a gene called MET.

Some cancer cells have a large number of copies of a gene called MET. This can happen in different types of cancers including

Having a large number of copies of the MET gene can make cancers more difficult to treat. In this trial, researchers are looking at a drug called AMG 337 which blocks the effects of the MET gene. This may help to stop the growth of cancer cells.

The aims of the trial are to

  • See if AMG 337 has an effect on cancers that have a large number of copies of the MET gene
  • Learn more about the side effects and what happens to the drug in your body

Who can enter

You may be able to join this trial if all of the following apply.

  • You have a solid tumour that has spread from where it started and there is no standard treatment available, or you don’t want to have the standard treatment
  • Your cancer has a large number of copies of the MET gene (this is called MET amplification). To check this, the trial team will test a sample of your cancer that was removed when you had surgery or a biopsy
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You have satisfactory blood test results
  • You are at least 18 years old

As well as the above, you must be willing to use 2 forms of reliable contraception if there is any chance you or your partner could become pregnant. Women must continue to do so for 2 weeks after the last dose of AMG 337 and must not breastfeed during this time. Men must carry on using 2 forms of contraception for 12 weeks after the last dose of AMG 337. They must not donate sperm during this time

You cannot join this trial if any of these apply. You

  • Have cancer that has spread to your brain or spinal cord (the central nervous system)
  • Are able to have surgery or a combination of chemotherapy and radiotherapy (chemoradiation)
  • Have had another experimental drug in the last 4 weeks
  • Have had major surgery in the last month or haven’t fully recovered from any recent minor surgery
  • Have any other cancer treatment (including radiotherapy) in the 2 weeks before joining the trial
  • Haven’t recovered from the side effects of any other cancer treatment
  • Have had any other cancer in the last 3 years, unless it was a very early stage and has been successfully treated (the trial team can advise you about this)
  • Have an infection that needs treatment with antibiotics in the week before joining the trial (if you have an uncomplicated urine infection you may be able to take part)
  • Have certain problems with your digestive system that could affect how you absorb drugs (the trial team can advise you about this)
  • Have had a heart attack in the last 6 months or have certain other heart problems (the trial team can advise you about this)
  • Have any other medical condition that the trial team think could affect your taking part
  • Take other drugs that can affect body substances called CYP enzymes in the 2 weeks before joining the trial (this includes St John’s Wort)
  • Have hepatitis C (you may be able to take part if you have hepatitis B, as long as the condition is stable)
  • Are HIV positive
  • Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The trial team need about 140 people to take part. This will include at least 100 people who have one of the following cancers

It will also include at least 40 people who have non small cell lung cancer.

Everybody joining the trial will take AMG 337 capsules once every day. As long as you don’t have bad side effects, you may be able to carry on taking the capsules for up to a year.

The trial team will ask the first 100 people joining the trial to fill out a questionnaire

  • Every 4 weeks for the first 3 months
  • Every 8 weeks for the next 6 months
  • Then every 12 weeks after that

The questionnaire will ask about side effects and how you’ve been feeling.  This is called a quality of life study.

They will also ask everybody taking part to keep a diary at home. In this, you note down when you take the capsules each day. You take the diary with you to every hospital appointment.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

You see the trial team every 2 weeks for the first month and then every 4 weeks after that. You have a physical examination and blood tests at each visit.

People taking part at certain hospitals have more hospital visits to have extra blood tests. The researchers use these blood samples to look at what happens to the drug in your body. This is called pharmacokinetics.

You have a CT or MRI scan every 8 weeks for the first 8 months and then every 12 weeks after that. You also have 3 more heart traces during treatment.

When you finish treatment, you see the trial team once more. They will then check how you are every 3 months. This may be at hospital appointments, or a member of the trial team may contact you by phone.

Side effects

As AMG 337 is a new drug, there may be side effects we don’t know about yet. The possible side effects include

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Anne Thomas

Supported by

Amgen
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 11978

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think

Share this page